n.a. 26168DERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048551096017), received between Aug 11, 2021 and Aug 11, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2021Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): IT WAS REPORTED THAT THE INSTRUMENT WAS RELEASED DURING AN OPERATION CAUSING PROBLEMS FOR THE PATIENT. FURTHER INFORMATION WAS REQUESTED, BUT NOT AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12309002 ↗